Last updated on: 10/22/2018 | Author: ProCon.org

Footnotes & Sources

The background and pro and con arguments were written by ProCon.org staff based upon input from the following footnotes (directly referenced) and sources (used for general research and not directly referenced):

Footnotes:

1.Jisu Huh, Denise E. DeLorme, Leonard N. Reid, and Soontae An, "Direct-to-Consumer Prescription Drug Advertising: History, Regulation, and Issues,” minnesotamedicine.com, Mar. 2010
2.Julie Donohue, "A History of Drug Advertising: The Evolving Roles of Consumers and Consumer Protection,” Milbank Quarterly, ncbi.nlm.nih.gov, Dec. 2006
3."Lydia E. Pinkham’s Vegetable Compound,” wikimedia.org, 1882
4.American Medical Association, "AMA History Timeline,” ama-assn.org (accessed Mar. 21, 2014)
5.FDA, "Milestones in Food and Drug Law History,” fda.gov, Feb. 2, 2009
6.P.M. Wax, "Elixirs, Diluents, and the Passage of the 1938 Federal Food, Drug and Cosmetic Act,” Annals of Internal Medicine, ncbi.nlm.nih.gov, Mar. 15, 1995
7.Vincent A. Kleinfeld and Charles Wesley Dunn, Federal Food, Drug, and Cosmetic Act: Judicial and Administrative Record, 1938-1949, 1949
8.GPO, "Federal Register Volume 77, Number 39,” gpo.gov, Feb. 28, 2012
9.James H. Kim and Anthony R. Scialli, "Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease,” Toxicological Sciences, toxsci.oxforjournals.org, Apr. 19, 2011
10.Matthew Arnold, "Direct-to-Consumer Report: DTC Drain,” mmm-online.com, Apr. 1, 2013
11.Carol Ballentine, "Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident, " fda.gov, June 1981
12.Jeremy A. Greene and David Herzberg, "HIDDEN in PLAIN SIGHT Marketing Prescription Drugs to Consumers in the Twentieth Century,” American Journal of Public Health, ncbi.nlm.nih.gov, May 2010
13.Lawrence K. Altman, "Briefs on the Doctor’s World,” nytimes, com, Aug. 17, 1982
14.Congressional Budget Office, "Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescription Drugs,” cbo.gov, May 26, 2011
15.PhRMA, "PhRMA Guiding Principles Direct to Consumer Advertisements about Prescription Medicines,” phrma.org, Dec. 2008
16.Davis & Gilbert LLP, "PHRMA Amends Voluntary Guidelines on DTC Advertising,” dglawcom, Feb. 10, 2009
17.FDA, "The Office of Prescription Drug Promotion (OPDP),” fda.gov, Mar. 6, 2014
18.World Health Organization, "Pharmaceutical Industry,” who.int (accessed Mar. 21, 2014)
19.FDA, "Office of Prescription Drug Promotion (OPDP) Research,” fda.gov, Mar. 19, 2013
20.Regulations.gov, "Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosure Regarding Additional Risks in Direct-to- Consumer Prescription Drug Television Advertisements,” regulations.gov, Feb. 18, 2014
2.1"Pure Food and Drug Act (1906). United State Statutes at Large (59th Cong., Sess. I, Chp. 3915, p. 768-772; cited as 34 U.S. Stats. 768)," Medicine in the Americas: Historical Works [Internet], ncbi.nlm.nih.gov
22.Institute of Medicine of the National Academies, "Clarify FDA’s Regulatory Authority,” iom.edu, Sep. 2006
23.Philip H. Dougherty, "Advertising; Pfizer’s Awareness Campaign,” nytimes.com, Feb. 7, 1985
24.Wendy Borrow, "The AMA Explains Its about-Face on Direct-to-Consumer Advertising. (American Medical Association),” highbeam.com, Sep. 1, 1993
25.FDA, "History of the U.S. Food and Drug Administration,” fda.gov, May 7, 1997
26.Henry J. Kaiser Family Foundation, "Impact of Direct-to-Consumer Advertising on Prescription Drug Spending," kff.org, June 2003
27.US Government Accountability Office (GAO), "Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-To-Consumer Advertising," pdf gao.gov, Nov. 2006
28.Michael R. Law, Stephen B. Soumerai, Alyce S. Adams, and Sumit R. Majumdar, "Costs and Consequences of Direct-to-Consumer Advertising for Clopidogrel in Medicaid,” Archives of Internal Medicine, Nov. 23, 2009
29.John LaMattina, "Maybe It’s Time for Drug Companies to Drop TV Ads,” forbes.com, Feb. 15, 2012
30.Andrew R. Payton and Peggy A. Thoits, "Medicalization, Direct-to-Consumer Advertising, and Mental Illness Stigma,” Society and Mental Health, Mar. 2011
31.Jeannine Stein, "There’s a Pill for That: Drug Prescriptions in the U.S. Hit a Record High,” takepart.com, Sep. 14, 2012
32.Rodale, "Prevention Magazine Releases 13th Annual DTC Survey Results,” rodaleinc.com, July 15, 2010
33.Matthew Herper, "The Truly Staggering Cost of Inventing New Drugs,” forbes.com, Feb. 10, 2012
34.Louis Jacobson, "Prevent Drug Companies from Blocking Generic Drugs,” politifact.com, Mar. 9, 2012
35.Dayne M. Porter, "Direct-to-Consumer (DTC) Pharmaceutical Marketing: Impacts and Policy Implications,” SPNHA Review, scholarworks.gvsu.edu, Oct. 19, 2011
36.FDA, "Basics of Drug Ads,” fda.gov, Sep. 13, 2012
37.Legal Information Institute, "Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc.,” law.cornell.edu (accessed Mar. 5, 2014)
38.WHO, "WHO Pharmaceuticals Newsletter,” who.int, 2007
39.WHO, "Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication,” who.int, 2000
40.Frank Auton, "Opinion: The Case for Advertising Pharmaceuticals Directly to Consumers,” Future Medicinal Chemistry, future-science.com, July 2009
41.Gregory A. Abel, Harold J. Burstein, Nathaneal D. Hevelone, and Jane C. Weeks, "Cancer-Related Direct-to-Consumer Advertising: Awareness, Perceptions, and Reported Impact among Patients Undergoing Active Cancer Treatment,” Journal of Clinical Oncology, Aug. 3, 2009
42.Richard Meyer, "Majority of Physicians Believe DTC Ads Should Be Cut Back,” worldofdtcmarketing.com, Apr. 30, 2013
43.Kathryn J. Aikin, John L Swasy, and Amie C. Braman, "Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs —Summary of FDA Survey Research Results,” fda.gov, Nov. 19, 2004
44.Ashish Parekh, Roland Marcus, Melissa Roberts, and Dennis W. Raisch, "Risks and Benefits of Direct to Consumer Advertising on Patient-Provider Relationships,” ispor.org, Nov. 2011
45.Taylor Tyler, "Direct-to-Consumer Drug Ads Should Be Scaled Back, Doctors Say,” ivn.us, June 3, 2013
46.C. Lee Ventola, "Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic?,” ncbi.nlm.nih.gov, Oct. 2011
47.Bruce Japsen, "Drug Makers Dial down TV Advertising,” nytimes.com, Feb. 2, 2012
48.Ann Marie Christensen, "TV Drug Ads: The Whole Truth?,” eurekaalert.org, Sep. 16, 2013
49.Adrienne E. Faerber and David H. Kreling, "Content Analysis of False and Misleading Claims in Television Advertising for Prescription and Nonprescription Drugs,” Journal of Internal Medicine, springer.com, Sep. 2013
50.FDA, "FDA – Adverse Event Reporting System (AERS): Freedom of Information (FOI) Report,” medicalmarijuana.procon.org (accessed Mar. 25, 2014)
51.Rachel Kornfield, "The Rise of TV Advertising for Prescription Cosmetic Pharmaceuticals,” healthmediacollaboratory.org, Aug. 20, 2013
52.AbbVie Inc , "Decreased Energy,” isitlowt.com (accessed Jan. 16, 2013)
53.Kurt C. Stange, "Consumer Drug Advertising Should Be Banned,” nytimes.com, Dec. 16, 2013
54.Trista Kelley, "The Big Bucks in Keeping Kids Focused,” businessweek.com, Oct. 10, 2013
55.Brenden L. Smith, "Inappropriate Prescribing,” apa.org, June 2012
56.Science Daily, "Many U.S. Physicians Often Fulfill Patient Requests for Brand-Name Drugs Instead of Equivalent Generics,” sciencedaily.com, Jan. 7, 2013
57.Uwe Reinhardt, interview with Frontline, pbs.org, Oct. 9, 2002
58.Alan Schwarz, "Report Says Medication Use Is Rising for Adults with Attention Disorder," nytimes.com, Mar. 12, 2014
59.Rebecca Robbins, "Drug Makers Now Spend $5 Billion a Year on Advertising. Here's What That Buys," statnews.com, Mar. 9, 2016
60.GlobalData "US Pharmaceutical Market Value Will Approach $550 Billion by 2020, Says GlobalData," healthcare.globaldata.com, Mar. 17, 2015
61.Bruce Horovitz and Julie Appleby, "Prescription Drug Costs Are Up; So Are TV Ads Promoting Them," usatoday.com, Mar. 16, 2017
62..Harvard T. H. Chan School of Public Health and STAT, "American's Attitudes about Changing Current Prescription Drug & Medical Device Regulation," harvard.edu, May 2016
63.Kristina Klara, Jeanie Kim, and Joseph S. Ross, "Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines," Journal of Internal General Medicine, Feb. 26, 2018
64Laura Entis, "DTC Pharma Ad Spending Slipped 4.6% in 2017: Kantar," mmm-online.com, Mar. 12, 2018

Sources:

Bayer Pharmaceutical Products, web.missouri.edu (accessed May 26, 2009)
FDA, "Guidance for Industry: Consumer-Directed Broadcast Advertisements," pdf fda.gov, Aug. 1999
Federal Food and Drug Act of 1906 - Public Law 59-384," fda.gov, 1906
Marc-Andre Gagnon and Joel Lexchin, "The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States," Public Library of Science Medicine, Jan. 2008
Sean Gregory, "Are Direct-to-Consumer Drug Ads Doomed?," TIME magazine, Feb. 4, 2009
IMS Health, "IMS Heatlh Reports U.S. Prescription Sales Grew 1.3 Percent in 2008 to $291 Billion," imshealth.com, Mar. 19, 2009
Kefauver Harris Amendments - Public Law 87-781," fda.gov, Oct. 10, 1962
Pharmaceutical Research and Manufacturers of America, "Pharmaceutical Marketing in Perspective: Its Value and Role as One of Many Factors Informing Prescribing," phrma.org (accessed June 1, 2009)
Pharmaceutical Research and Manufacturers of America, "Testimony and Official Submissions," phrma.org, Sep. 29, 2005
Pharmaceutical Research and Manufacturers of America, "The Facts About Pharmaceutical Marketing & Promotion," phrma.org (accessed June 1, 2009)
Science Daily, "Big Pharma Spends More on Advertising Than Research and Development, Study Finds," sciencedaily.com, Jan. 7, 2009
US Food and Drug Administration (FDA), "A History of the FDS and Drug Regulation in the United States," fda.gov (accessed June 1, 2009)
US Food and Drug Administration (FDA), "Drugs and Foods under the 1938 Act and Its Amendments, fda.gov (accessed June 1, 2009)
US Food and Drug Administration (FDA), "Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs - Summary of FDA Survey Research Results," fda.gov, Nov. 19, 2004
US Food and Drug Administration (FDA), "The 1906 Food and Drugs Act and Its Enformement," fda.gov (accessed June 1, 2009)
US Food and Drug Administration (FDA), "The 1938 Food, Drug, and Cosmetic Act," fda.gov (accessed June 1, 2009)
Keith J. Winstein and Suzanne Vranica, "Drug Firms' Spending on Consumer Ads Fell 8% in '08, a Rare Marketing Pullback, Wall Street Journal, Apr. 16, 2009